Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Sep 18, 2023; 14(9): 707-719
Published online Sep 18, 2023. doi: 10.5312/wjo.v14.i9.707
Use of orthotics with orthotic sandals versus the sole use of orthotics for plantar fasciitis: Randomised controlled trial
Portia Amoako-Tawiah, Holly Love, Jaida Chacko Madathilethu, Jessica LaCourse, Alice E Fortune, Jonathan M G Sims, George Ampat
Portia Amoako-Tawiah, Holly Love, Jessica LaCourse, Alice E Fortune, George Ampat, School of Medicine, University of Liverpool, Merseyside, Liverpool L69 3GE, United Kingdom
Jaida Chacko Madathilethu, Urology, Royal Stoke University Hospital, Staffordshire, Stoke ST4 6QG, United Kingdom
Jonathan M G Sims, George Ampat, Research Unit, Talita Cumi Ltd., Merseyside, Southport PR8 3NS, United Kingdom
Author contributions: Ampat G supervises the research team and acquired the funding; Ampat G and Sims JMG conceptualised the study and were involved in protocol development and gaining ethical approval; Ampat G and Sims JMG were involved in participant recruitment and data acquisition; Amoako-Tawiah P, Love H, Chacko Madathilethu J, LaCourse J, Fortune AE, and Sims JMG wrote the manuscript; All authors reviewed and edited the manuscript and approved the final draft.
Supported by Aetrex, Inc. 414 Alfred Avenue Teaneck, NJ 07666, United States.
Institutional review board statement: The study was reviewed and approved by the Wales Research Ethics Committee 5.
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: George Ampat and Jonathan M G Sims are employees of Talita Cumi Ltd, which has a commercial relationship with Aetrex Worldwide, Inc. 414 Alfred Avenue Teaneck, NJ 07666, United States. All other authors have no conflict of interest to declare.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: George Ampat, FRCS, FRCS (Gen Surg), MBBS, Consultant Physician-Scientist, Doctor, Lecturer, School of Medicine, University of Liverpool, Cedar House, Ashton St, Merseyside, Liverpool L69 3GE, United Kingdom.
Received: April 13, 2023
Peer-review started: April 13, 2023
First decision: July 4, 2023
Revised: August 3, 2023
Accepted: August 21, 2023
Article in press: August 21, 2023
Published online: September 18, 2023
Research background

Prefabricated orthotics with arch support provides symptom relief in plantar fasciitis (PF) but are only effective when shoes are worn. Hence, the foot may be left unsupported when it is impractical to wear shoes, such as in the morning or evening at home. Utilising orthotic sandals in conjunction with prefabricated orthotics may enhance symptom relief for PF patients, as they can be worn inside the home, thereby extending the period in which the foot is supported. Prefabricated orthotics and orthotic sandals have been investigated as treatment methods for PF independently, but not in combination.

Research motivation

PF affects around 10% of the population. The resulting pain can cause activity avoidance, disability, and reduced quality of life. However, the natural history of PF is that it resolves naturally with time. Unfortunately, it remains symptomatic during the active phase and requires intervention for pain relief and symptom improvement. As most cases of PF spontaneously resolve with the passage of time, it is needless to burden the already overburdened healthcare system to address this disorder. This trial sought to identify the superiority between two drug-free and non-invasive treatment modalities to address plantar heel pain which can be used as a self-help measure by patients.

Research objectives

To compare the combined use of orthotics and orthotic sandals vs the sole use of orthotics in the treatment of PF.

Research methods

104 participants were randomly assigned to the intervention group, who received both prefabricated orthotics and orthotics sandals, or the control group, who received prefabricated orthotics only. Participants were instructed to use the devices as much as possible. Data were collected at baseline, three weeks, six weeks, three months, and six months. Foot pain was assessed using an 11-point numerical rating scale (NRS). Foot pain and functionality were assessed using the foot pain and foot functionality sub-scales of the foot health status questionnaire (FHSQ). The global rating of change score (GROC) was provided at three weeks, six weeks, three months and six months to assess PF symptom change. A series of Wilcoxon signed-rank tests, Mann-Whitney U tests, Paired T-tests and independent sample t-tests were performed for analysis.

Research results

Foot pain scores significantly improved in both groups, as assessed and measured by the NRS and FHSQ pain sub-scale. Significant improvements in function by the FHSQ function subscale and changes in the level of symptoms by the GROC scale were also observed in both groups. The combined use of orthotics and orthotic sandals showed superior outcomes on all four measures but only reached statistical significance on the NRS pain scales.

Research conclusions

This study provides evidence that both the combined use of orthotics and orthotic sandals and the sole use of orthotics alone, improve pain and function significantly in PF patients. Between-group differences show that the combined use does provide a greater decrease in foot pain compared to using orthotics alone.

Research perspectives

Though this study provides evidence that the combined use of prefabricated orthotics and orthotic sandals improves foot pain in PF patients more than the use of prefabricated orthotics alone, it was not without limitation. Hence, future research should aim to address these limitations, including collecting data on participants’ duration of PF symptoms on enrolment, and risk factors for the condition.